English to Russian Medical Medical: Pharmaceuticals

Parameter: Specificity

Acceptance Criteria: Peaks that are present in chromatograms of the blank, placebo and aged placebo (stored at 60°C/60%RH for 2 weeks) must not significantly interfere with the active. The interference with the active must be no greater than 10% of the specification range or 0.5% of the response at the target concentration, whichever is less.

Result: Peaks present in the chromatograms of the blank, placebo and aged placebo did not interfere with the proper integration of nicergoline peak.